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Clinical Trial for the Prevention of Vasovagal Syncope

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ClinicalTrials.gov Identifier: NCT00118482
Recruitment Status : Completed
First Posted : July 11, 2005
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr. Bob Sheldon, University of Calgary

Tracking Information
First Submitted Date  ICMJE June 30, 2005
First Posted Date  ICMJE July 11, 2005
Results First Submitted Date  ICMJE October 26, 2016
Results First Posted Date  ICMJE June 28, 2017
Last Update Posted Date June 28, 2017
Study Start Date  ICMJE May 2005
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2017)
The Primary Outcome Measure Will be the Recurrence of Syncope in Follow up Period. [ Time Frame: Within 12 months ]
This will be measured in terms of number of patients that had at least 1 syncopal spell in the 12 month follow up period.
Original Primary Outcome Measures  ICMJE
 (submitted: June 30, 2005)
The primary outcome measure will be the time to the first recurrence of syncope.
Change History Complete list of historical versions of study NCT00118482 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2017)
  • The Frequency of Syncope Will be the First Secondary Outcome Measure. [ Time Frame: Within 12 months ]
    Frequency will be reported as 12- month syncope event rates (%)
  • Presyncope Frequency, Duration, and Intensity Will be the Second Secondary Outcome Measures, Both Alone and in a Composite Score. [ Time Frame: Within 12 months ]
  • Quality of Life Will be the Third Secondary Outcome Measure. The Investigators Will Compare the Quality of Life in Treated and Untreated Patients. [ Time Frame: 12 months ]
    Quality of life will be the third secondary outcome measure. The investigators will compare the quality of life in patients on fludrocortisone vs placebo
Original Secondary Outcome Measures  ICMJE
 (submitted: June 30, 2005)
  • The Frequency of Syncope Will be the First Secondary Outcome Measure.
  • Presyncope Frequency, Duration, and Intensity Will be the Second Secondary Outcome Measures, Both Alone and in a Composite Score.
  • Quality of Life Will be the Third Secondary Outcome Measure. The Investigators Will Compare the Quality of Life in Treated and Untreated Patients.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial for the Prevention of Vasovagal Syncope
Official Title  ICMJE A Randomized Clinical Trial of Fludrocortisone for Vasovagal Syncope: The Second Prevention of Syncope Trial (POST II)
Brief Summary

The main question in the study is whether people taking fludrocortisone are less likely to faint than people taking an inactive pill called a placebo.

Fludrocortisone is a drug that stimulates the body to retain salt and water. The investigators know from some studies that it might prevent people from fainting at home and in the community, while they are carrying on with their lives. There is some evidence that salt and water retention help prevent fainting, but no one has a clear idea about whether this is true. This study will try to determine if that is true.

Detailed Description

About 10% of adults faint recurrently. These patients are often highly symptomatic, have problems with employment and driving, and have well-documented reduced quality of life. There are no therapies that have withstood the test of adequately conducted and credible randomized clinical trials.

There is ample evidence of the importance of blood volume in the pathophysiology of vasovagal syncope. Fludrocortisone acetate is a corticosteroid with a mild enhancement of glucocorticoid activity and a marked increase in mineralocorticoid activity. It has no appreciable glucocorticoid effect at doses between 0.05 to 0.2 mg, which are the commonly used clinical doses for various disorders requiring mineralocorticoid adrenal replacement. The acute actions of fludrocortisone acetate are sodium and water retention, at the expense of urinary potassium excretion. Blood volume expansion with either dietary salt supplementation or fludrocortisone is often recommended by clinicians for the treatment of vasovagal syncope despite a paucity of good evidence for their efficacy. Four clinical studies suggest its utility in the prevention of syncope. Fludrocortisone might decrease the incidence of vasovagal syncope, but the quality of the evidence supporting its use is poor. There are no randomized, placebo-controlled trials of fludrocortisone for the prevention of vasovagal syncope. In this 5-year study the investigators will test the hypothesis that fludrocortisone prevents recurrences of vasovagal syncope.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Syncope, Vasovagal, Neurally-Mediated
Intervention  ICMJE Drug: fludrocortisone acetate
Fludrocortisone acetate to a maximum of 0.2 mg daily Placebo to a maximum of 0.2 mg daily
Study Arms  ICMJE
  • Experimental: fludrocortisone acetate
    Intervention: Drug: fludrocortisone acetate
  • Placebo Comparator: Placebo
    Intervention: Drug: fludrocortisone acetate
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 25, 2017)
213
Original Enrollment  ICMJE
 (submitted: June 30, 2005)
310
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Syncope as a cause of loss of consciousness according to European Society of Cardiology criteria
  • > 2 lifetime syncopal spells preceding enrollment
  • > or = to -2 points on the Syncope Symptom Score for Structurally Normal Hearts
  • Age > 18 years with informed consent, or age > 14 years with consent and informed parental consent

Exclusion Criteria:

  • Other causes of syncope, such as ventricular tachycardia, complete heart block, postural (orthostatic) hypotension or hypersensitive carotid sinus syndrome
  • An inability to give informed consent
  • Important valvular, coronary, myocardial or conduction abnormality or significant arrhythmia
  • Hypertrophic cardiomyopathy
  • A known intolerance to fludrocortisone
  • Another clinical need for fludrocortisone that cannot be met with other drugs
  • A permanent pacemaker
  • A seizure disorder
  • A major chronic non cardiovascular disease
  • Hypertension (blood pressure ≥ 130/85 on 2 occasions) or heart failure
  • Renal dysfunction (baseline glomerular filtration rate reduced below 60 ml/min/1.73m2 according to the Cockroft-Gault formula)
  • Diabetes mellitus
  • Hepatic disease
  • Glaucoma
  • Any prior use of fludrocortisone acetate
  • A 5-minute stand test resulting in diagnosis of postural orthostatic tachycardia syndrome or orthostatic hypotension
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00118482
Other Study ID Numbers  ICMJE 130312
ISRCTN51802652
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Bob Sheldon, University of Calgary
Study Sponsor  ICMJE University of Calgary
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Robert S. Sheldon, MD PhD University of Calgary, Faculty of Medicine
PRS Account University of Calgary
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP